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Active Not Recruiting
NCT06251180
Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma
Conditions: B-cell Non-Hodgkin Lymphoma
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 112
Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
Location: Sun Yat-sen University Cancer Center Guangzhou Guangdong
Summary
This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma \[Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)\].
Eligibility Criteria
Inclusion Criteria:
* Participants was histopathologically diagnosed with any of the following diseases: DLBCL, MZL or MCL (if enrolled in the dose expansion phase, histological confirmation of non-GCB subtype), and have not previously received anti-tumor systemic therapy or local radiation therapy for the above diseases.
* Participants must have at least one measurable lesion.
* ECOG physical status score 0-2.
* Life expectancy ≥6 months.
* International Prognostic Index (IPI) score ≥ 2 (only participants with DLBCL in dose expansion portion).
* Adequate coagulation, liver, kidney, and hematopoietic functions:PT and APTT \
Source: ClinicalTrials.gov (NCT06251180). StuddyBuddy aggregates publicly available trial information.